a study to evaluate the efficacy and safety of ertugliflozin in asian participants with type 2 diabetes and inadequate glycemic control on metformin monotherapy (mk-8835-012)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study to evaluate the efficacy and safety of the addition of ertugliflozin to metformin monotherapy in asian participants with type 2 diabetes mellitis (t2dm) who have inadequate glycemic control on metformin monotherapy. the primary hypothesis is that the mean reduction from baseline in hba1c for 15 mg and 5 mg ertugliflozin (tested sequentially) is greater than for placebo.

this study includes a 1-week screening period, an 8-week (or greater) antihyperglycemic agent (aha) wash-off and/or metformin dose stable period (as necessary), a 2-week single-blind placebo run-in period, a 26-week double-blind treatment period, and a post-treatment telephone contact 14 days after the last dose of study drug.

Eligibility criteria:
inclusion criteria: * asian participants ≥18 years of age at the time of initial screening. * type 2 diabetes mellitus as per american diabetes association guidelines. * metformin monotherapy (≥1500 mg/day) with an initial screening a1c of 7.0-10.5% (53-91 mmol/mol) or metformin monotherapy (\<1500 mg/day) with an initial screening a1c of 7.5-11.0% (58-97 mmol/mol) or dual combination therapy with metformin + sulfonylurea, dipeptidyl peptidase-4 (ddp-4) inhibitor, meglitinide, or alpha-glucosidase inhibitor with an initial screening a1c of 6.5-9.5% (48-80 mmol/mol). * body mass index (bmi) ≥18.0 kg/m\^2. * male or female not of reproductive potential. * female of reproductive potential who agrees to remain abstinent from heterosexual activity or to use 2 acceptable combinations of contraception. exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis. * history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant.) * history of myocardial infarction, unstable angina, arterial revascularization, stroke, transient ischemic attack, or new york heart association (nyha) functional class iii-iv heart failure within 3 months of study start. * mean value for triplicate screening sitting systolic blood pressure \>160 mm hg and/or diastolic blood pressure \>90 mm hg after at least a 5-minute seated rest at screening * active, obstructive uropathy or indwelling urinary catheter. * history of malignancy ≤5 years prior to study start, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * routinely consumes \>2 alcoholic drinks per day or \>14 alcoholic drinks per week or engages in binge drinking. * any clinically significant malabsorption condition. * is on a weight-loss program or weight-loss medication or other medication associated with weight changes and is not weight stable prior to study start. * has undergone bariatric surgery within the past 12 months or \>12 months and is not weight stable prior to study start. * a known hypersensitivity or intolerance to any sodium glucose co-transporter (sglt2) inhibitor. * on a previous clinical study with ertugliflozin. * is taking blood pressure or lipid altering medications that have not been on a stable dose for at least 4 weeks prior to study start. * current treatment for hyperthyroidism. * male participants with a serum creatinine \>=1.3 mg/dl (\>=115 mol/l) or female participants with a serum creatinine \>=1.2 mg/dl (\>=106 mol/l) or participants with an estimated glomerular filtration rate (egfr) \<55 ml/min/1.73m\^2 according to the 4-variable modification of diet in renal disease (mdrd) equation at screening. * an aspartate transaminase (ast) or alanine transaminase (alt) \>2x the upper limit of normal (uln) range at screening, or a total bilirubin \>1.5 x the uln unless the participant has a history of gilbert's. * on thyroid replacement therapy and has not been on a stable dose for at least 6 weeks prior to study start. * a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis b or c, primary biliary cirrhosis, or symptomatic gallbladder disease. * has been treated with any of the following agents within 12 weeks of study start or during the pre-randomization period: insulin of any type (except for short-term use during concomitant illness or other stress), other injectable anti-hyperglycemic agents (e.g., pramlintide, exenatide, liraglutide), another sglt2 inhibitor, bromocriptine, colesevelam, rosiglitazone or pioglitazone, or any other aha with the exception of the protocol-approved agents. * is on or likely to require treatment ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids. * has undergone a surgical procedure within 6 weeks prior to study start or has planned major surgery during the study. * pregnant or breast-feeding, or planning to conceive during the trial, including 14 days following the last dose of study medication. * planning to undergo hormonal therapy in preparation for egg donation during the trial, including 14 days following the last dose of study medication. * donated blood or blood products within 6 weeks of study start. * has human immunodeficiency virus (hiv). * has blood dyscrasias or any disorders causing hemolysis or unstable red blood cells. * has clinically important hematological disorders (such as aplastic anemia, myeloproliferative or myelodyplastic syndromes, thrombocytopenia.)